Propofol Spinal Procedural Sedation for Cesarean Section

• Sponsor: Mansoura University (Other)
• Overall Status: Completed
• CT.gov ID: NCT03437980
• Collaborator: (none)
• Enrollment: 228
• Locations: 3
• Arm: 1
• Actual Duration (Months): 5.3
• Patients Per Site: 76
• Patients Per Site Per Month: 14.3

Study Details

Study Description

Brief Summary

Patient's safety and satisfaction are major concerns of anesthesiologists and obstetricians. According to evidence, guidelines and quality markers, regional anesthesia is preferred over general anesthesia in obstetric surgery. A high level of anxiety is present in obstetric patients preoperatively. Patients with high anxiety tend to prefer general anesthesia for cesarean section. The anxiety can be reduced variably by non-pharmacologic and pharmacologic methods. The evidence supports the benefits of procedural sedation for distressed, anxious pregnant women.

Condition or Disease	Intervention/Treatment	Phase
Patient Compliance	Drug: propofol	N/A

Detailed Description

Propofol provides short onset, rapid predictable action, anxiolysis and amnesia and it is more effective than benzodiazepines. Using propofol infusion in low doses during spinal injection in CS did not adversely affect the Apgar scores or the neurological and adaptive fetal outcomes. The general consensus is that procedural sedation is not a routine for spinal interventions, but required for anxious patients. Our hypothesis is that, with the high prevalence of maternal anxiety during cesarean section, ensuring painless comfortable spinal anesthesia may increase the acceptance rate of regional anesthesia during cesarean section.

Study Design

• Study Type: Interventional
• Actual Enrollment: 228 participants
• Allocation: N/A
• Intervention Model: Single Group Assignment
• Masking: None (Open Label)
• Primary Purpose: Supportive Care
• Official Title: Can Propofol Procedural Sedation Implementation Increase the Acceptance of Spinal Anesthesia During Cesarean Section?
• Actual Study Start Date: Apr 1, 2018
• Actual Primary Completion Date: Jul 10, 2018
• Actual Study Completion Date: Sep 10, 2018

Arms and Interventions

Arm

Intervention/Treatment

Experimental: propofol spinal acceptance The surgeon and the anesthetist will discuss the exclusion criteria. Then they will discuss the information's about spinal and general anesthesia with the illegible patients, also reply the patient's questions in a preoperative visit. The primary decision for the patient; either spinal or general anesthesia will be recorded. The patients refusing spinal anesthesia will be discussed again to detect the rate of acceptance of spinal anesthesia if propofol sedation is ensured during the procedure to provide a painless spinal injection. The final decision will be applied; either spinal with procedural sedation, or general anesthesia.

Drug: propofol; A bolus of 0.7 mg/kg will be given initially, additional incremental doses of 20 mg propofol will be given if the patient complained of pain or moved arms towards the back. Patients will be sitting on the middle of the operating table facing towards the table's foot. The table's foot will be dropped 45 degrees for a comfortable chair position, Monitoring through pulse oximeter (SaO2), non-invasive blood pressure (NIBP) adjusted every 2 minutes automatic measuring and capnography tube in contact with nostrils.; Other Names: propofol procedural sedation

Outcome Measures

Primary Outcome Measures

1. The rate of acceptance of spinal anesthesia if propofol sedation is added during the procedure. [30 minutes preoperative.]

   percent

Secondary Outcome Measures

1. The rate of initial acceptance of spinal anesthesia without sedation. [30 minutes preoperative.]

   percent

2. The anxiety score. [30 minutes preoperative,10 minutes after spinal injection, and 30 minutes after stay at recovery room.]

   by the visual analogue score from 0-10, where 10 is the maximum anxiety level.

Other Outcome Measures

1. The patient satisfaction regards the spinal anesthesia decision. [30 minutes at recovery room.]

   The patients express thier satisfaction with the spinal decision on a visual analogue score, ranging from 0 to 10, where 0 is the minimum and 10 is the maximum satisfaction level.

2. The total utilized dose of propofol. [1 minute after completion of spinal procedure, and 5 minutes at the end of cesarean section.]

   milligram

3. The rate of premature termination of spinal procedure (failure rate). [20 minutes preoperative.]

   percent

4. The sedation score. [determined 1 minutes after following spinal injection. then again after 10 minutes.]

   using modified Ramsay scale, 1. Anxious, 2. Cooperative, oriented, tranquil. 3. Responsive to commands only. If Asleep. 4. Brisk response to light glabellar tap or loud auditory stimulus. 5. Sluggish response to light glabellar tap or loud auditory stimulus.

5. The infant Apgar score. [0 and 5 minutes after delivery.]

   A measure of the physical condition of a newborn infant. Adding points (2, 1, or 0) for heart rate, respiratory effort, muscle tone, response to stimulation, and skin coloration; ranges from 0- 10, score of ten represents the best possible condition.

6. Patient's choice of anesthesia next time. [30 minutes after shifting the patient to recovery room.]

   spinal or general anesthesia.

7. The incidence of desaturation during propofol spinal procedural sedation. [20 minutes preoperative.]

   in percent, desaturation defined as oxygen saturation less than 90%

8. The incidence of hypotension during propofol spinal procedural sedation. [20 minutes preoperative.]

   in percent, hypotension defined as mean blood pressure less than 60 millimeter mercury.

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years to 40 Years
• Sexes Eligible for Study: Female
• Accepts Healthy Volunteers: No

Inclusion Criteria:

• Patients scheduled for elective cesarean section,

• Age: 18 - 40 years,

• American Society of Anesthesiologists I - III,

• Patients may present any of the following conditions:

• Respiratory diseases as bronchial asthma

• Hepatic compromise,

• Preeclampsia,

• Anemia with hemoglobin 10 g/dl,

• Previous sections,

• Obese with BMI more than 35%,

• Any criteria of difficult intubation, Compromised fetus as premature delivery, History of complications or non-satisfaction after general anesthesia during previous cesarean section,

Exclusion Criteria:

• Patients refusing to participate in the study,

• Known psychiatric disease,

• Addiction medications,

• Communication barrier,

• Absolute or relative contraindication for spinal anesthesia,

• Bad obstetric history, complicated pregnancy, congenital fetal anomaly.

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Delta Hospital	Mansourah	Dakahlya	Egypt	35516
2	Mansoura University Hospital	Mansourah	Dakahlya	Egypt	35516
3	Zagazig University Hospital	Zagazig	Sharkya	Egypt	44519

Sponsors and Collaborators

• Mansoura University

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: Alaa Mazy Mazy, associate professor of anesthesia and surgical intensive care, Mansoura University
• ClinicalTrials.gov Identifier: NCT03437980
• Other Study ID Numbers: R.18.02.23
• First Posted: Feb 19, 2018
• Last Update Posted: Sep 18, 2020
• Last Verified: Sep 1, 2020

• Individual Participant Data (IPD) Sharing Statement: Undecided
• Plan to Share IPD: Undecided
• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: No
• Additional relevant MeSH terms: Propofol

Study Results

No Results Posted as of Sep 18, 2020